欧盟标准 EN 12182 欧盟市场洗澡椅/凳/便椅

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详细介绍

Test item 测试名称: 残疾人辅助器具 Technical aids for disabled persons

Bath Stool/ Chair/Toilet Chair for EU Market (BS EN 12182) 欧盟市场洗澡椅/凳/便椅
Clause	Test Category试验类别
EN 12182 Technical aids for disabled persons- General requirements and test methods 残疾人技术辅助设备一般要求和试验方法
4	General Requirements 一般要求
4.1	Risk Analysis 风险分析
4.1	Risk Analysis 风险分析
4.2	Intended performance and technical documentation 预期性能和技术文件
4.3	Clinical evaluation 临床评价
4.4	Aids that can be dismantled 可以拆卸的辅助设备
4.5	Single use fasteners 一次性紧固件
4.6	User mass limits 用户重量限制
4.7	Immobilising means 固定手段
4.8	Design requirements in relation to persons with cognitive impairment 认知障碍人士的设计要求
5	Materials 材料
5.2	Flammability可燃性
5.3	Biocompatibility and Toxicity (ISO10993-5 & 10) 生物相容性及毒性(iso10993-5及10)	applicable for upholstered parts, mattress or bedding. 适用于软垫、床垫或床上用品


5.4	Contaminants and residues (ISO 10993-1) 污染物及残余物(iso10993-1)


5.5	Infection and microbiological contamination 感染及微生物污染
5.6	Resistance to corrosion (ISO 9227, 168h) 耐腐蚀性(iso 9227,168h)	applicable for noise and vibration are not part of the intended performance of an assistive product（适用于噪音和振动不是辅助产品预期性能的一部分） applicable for electrical or electronic devices/components （适用于电气绝缘和带电部件） applicable for electrical appliance （适用于电器 ) applicable for electrical insulation and live parts 适用于电气绝缘和带电部件
6	Emitted sound and vibration 发出声音和振动
7	Electromagnetic compatibility 电磁兼容性
8	Electrical Safety 电气安全
9.1	Overflow 溢出
9.2	Spillage 溢出
9.3	Leakage 渗漏
9.4	Ingress of liquids 液体进入
10	Surface temperature 表面温度
11	Sterility 无菌测试	applicable if the assistive product is intended to be sterilised 适用于拟进行消毒的辅助产品
12	Safety of moving parts 活动部件的安全性
13	Prevention of traps for parts of the human body 防止人体部分陷阱
14	Folding and adjusting mechanisms 折叠和调节机构
15	Carrying handles (if applicable) 搬运手柄(如适用)
16	Assistive products which support or suspend users 支持或暂停用户的辅助产品
16.2	Static forces静力
16.3	Dynamic forces动力
16.4.2	Friction of tips ( ref. to ISO 24415 -1) 摩擦力(参考 iso 24415-1)	applicable only if the assistive products are provided with a tip 只适用于附有小费的辅助产品
16.4.3	Durability of tips ( ref. to ISO 24415 -2) 贴士的耐用性(参考 iso24415-2)
18	Surfaces, corners and edges 表面，角落和边缘
19	Hand held assistive products 手提式辅助产品
20	Small parts小零件
21	Stability稳定性
22	Forces in soft tissues of the human body 对人体软组织的作用力	risk analysis风险分析
23	Ergonomic principles 人类工程学原理
24	Requirements for information supplied by the manufacturer 制造商提供资料的规定
Sample size: 3 sets of completed products with all the packaging material/instruction 样本量: 3套成品及所有包装物料/说明书(物料除外)
TAT: 15 working days: 15个工作天